NCT02004613

Brief Summary

Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
798

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2013

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 9, 2013

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2020

Completed
4 months until next milestone

Results Posted

Study results publicly available

April 6, 2021

Completed
Last Updated

April 6, 2021

Status Verified

March 1, 2021

Enrollment Period

5.5 years

First QC Date

August 1, 2013

Results QC Date

December 18, 2020

Last Update Submit

March 12, 2021

Conditions

Heart Disease

Outcome Measures

Primary Outcomes (2)

  • Number of Patients With Atrial Arrhythmia

    The occurrence of postoperative atrial arrhythmias

    From the end of surgery to postoperative day 5

  • Number of Patients With Delirium

    The occurrence of postoperative delirium

    From the end of surgery to postoperative day 5

Secondary Outcomes (2)

  • Number of Patients With Acute Kidney Injury

    From the end of surgery to postoperative day 5

  • Number of Patients With Incisional Pain

    90 days after surgery

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

Dexmedetomidine infusion, without a bolus dose, (or a comparable volume of placebo) will be initiated before the surgical incision at a rate of 0.1 mcg/kg/hr at the end of bypass, the dose will be increased to 0.2 mcg/kg/hr. Postoperatively patients will continue to receive the study medication at a rate of 0.4mcg/kg/hr. The study medication infusion will be continued for a total of 24 hours from the initial administration time intra-operatively.

Drug: Dexmedetomidine

Placebo

PLACEBO COMPARATOR

normal saline administration matching dexmedetomidine rate of infusion.

Drug: Placebo

Interventions

DexmedetomidineDRUG

Dexmedetomidine

Dexmedetomidine
PlaceboDRUG

Normal saline administration matching dexmedetomidine rate of infusion

Also known as: Saline
Placebo

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old;
  • Scheduled for cardiac surgery with bypass (CABG, valve, or combined);
  • Able to provide a written informed consent;
  • Hemodynamically stable (heart rate\>= 55).

You may not qualify if:

  • Sick sinus syndrome or Wolff-Parkinson-White syndrome
  • Atrio-ventricular block
  • Hypersensitivity or known allergy to dexmedetomidine
  • Hepatic disease, e.g. twice the normal level of liver enzymes
  • Atrial fibrillation within 1 preoperative month;
  • Permanent pacemaker;
  • Use of amiodarone or dexmedetomidine within the last 30 days;
  • Patients with an ejection fraction under 30% or who had severe heart failure
  • Myocardial infarction in the previ¬ous 7 days;
  • Body mass index =\< 40 (BMI= mass (kg) / height (m)2);
  • Those taking clonidine within last 48 hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Main

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

  • Turan A, Duncan A, Leung S, Karimi N, Fang J, Mao G, Hargrave J, Gillinov M, Trombetta C, Ayad S, Hassan M, Feider A, Howard-Quijano K, Ruetzler K, Sessler DI; DECADE Study Group. Dexmedetomidine for reduction of atrial fibrillation and delirium after cardiac surgery (DECADE): a randomised placebo-controlled trial. Lancet. 2020 Jul 18;396(10245):177-185. doi: 10.1016/S0140-6736(20)30631-0.

    PMID: 32682483DERIVED

MeSH Terms

Conditions

Heart Diseases

Interventions

DexmedetomidineSodium Chloride

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Results Point of Contact

Title
Dr. Alparslan Turan
Organization
Cleveland Clinic Foundation
turana@ccf.org
216-445-9857

Study Officials

  • Alparslan Turan, MD

    Staff member

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff

Study Record Dates

First Submitted

August 1, 2013

First Posted

December 9, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2018

Study Completion

December 18, 2020

Last Updated

April 6, 2021

Results First Posted

April 6, 2021

Record last verified: 2021-03

Locations

US(1)